Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria

Exclusion Criteria

• •1. Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the Investigator.
• •2. Presence or history of any condition or procedure (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• •3. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to admission on Day -7 or unwilling to forego other forms of investigational treatment during this study.
• •4. Major surgery or an inpatient hospital stay within 3 months prior to admission on Day -7.
• •5. A positive serologic test for infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus.
• •6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 × upper limit of normal (ULN).
• •7. Hemoglobin A1c (HbA1c) ≥6.5 percent.
• •8. Hyperthyroidism or hypothyroidism as defined by thyroid-stimulating hormone (TSH) levels outside the normal reference range.
• •9. History of QT prolongation or dysrhythmia or a family history of prolonged QT interval or sudden death.
• •10. Use of prescription drugs (except for hormonal contraceptives) including cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine within 4 weeks prior to Screening and unable or unwilling to refrain from such use through the end of study visit.
• •11. Use of any herbal or over-the-counter medications, probiotic products, or vitamin supplements, including vitamin C, within 14 days prior to first administration of study drug through the end of the Confinement Period.
• •12. Planned procedures that may require antibiotics between Screening and the end of study visit.
• •13. Use of antibiotic treatment up to 4 weeks prior to or during Screening, or between Screening and admission (Day -7), or a history of recurrent infections requiring antibiotics.
• •14. A known hypersensitivity to MiraLax, clarithromycin, erythromycin, any of the macrolide antibiotics, metronidazole or other nitroimidazole derivatives.
• •15. A history of kidney stones.
• •16. Unwilling to comply with all study procedures and assessments, including the High Oxalate Low Calcium (HOLC) diet and the pretreatment regimen, which includes antibiotics.
• •1. Presence or history of any significant cardiovascular, gastrointestinal, hepatic, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease, as determined by the Investigator.
• •2. Presence or history of any condition or procedure (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
• •3. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to Visit 1 (Day -7) or are not willing to forego other forms of investigational treatment during this study.
• •4. Major surgery or an inpatient hospital stay within 3 months prior to Visit 1 (Day -7).
• •5. Uncontrolled hypertension with systolic blood pressure \>160 mmHg and diastolic blood pressure \>100 mmHg.
• •6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2 × upper limit of normal (ULN) or total bilirubin \>1 × ULN at Screening unless the patient has known Gilbert's syndrome.
• •7. Hemoglobin A1c (HbA1c) ≥6.5 percent.
• •8. Hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) levels outside the normal reference range.
• •9. History of QT prolongation or dysrhythmia, or a family history of prolonged QT interval or sudden death.
• •10. Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m2 calculated using the CKD-EPI equation.
• •11. Loose or liquid stools (Bristol Stool Scale Type 6 or 7) within 1 week prior to or during Screening.
• •12. Consumption of any herbal medications, probiotic products, or vitamin supplements, including vitamin C, within 14 days prior to first administration of study drug through the end of the Treatment Period.
• •13. Chronic therapy with high doses of systemic steroids (\>10 mg/day prednisone or equivalent daily) or intensification of existing immunosuppressant or immunomodulatory therapy for treatment of an acute disease flare within 4 weeks prior to or during Screening.
• •14. Planned procedures that may require antibiotics between Screening and the end of study visit.
• •15. Use of antibiotic treatment up to 4 weeks prior to or during Screening, or between Screening and Visit 1 (Day -7), or a history of recurrent infections requiring antibiotics.
• •16. A known hypersensitivity to MiraLax, clarithromycin, erythromycin, any of the macrolide antibiotics, metronidazole, or other nitroimidazole derivatives.
• •17. Unable or unwilling to discontinue use of cisapride, pimozide, astemizole, terfenadine, ergotamine, or dihydroergotamine from Visit 1 (Day -7) through the end of study visit.
• •18. A known genetic, congenital, or other known causes of kidney stones (eg, primary hyperoxaluria, cystinuria, primary hyperparathyroidism, or medullary sponge kidney).
• •19. A history of Roux-en-Y gastric bypass or other bariatric surgery procedures within 6 months prior to Screening.
• •20. Inflammatory bowel disease that is clinically unstable or have a change in medication to control disease activity within 4 weeks prior to Screening.
• •21. Unwilling to comply with all study procedures and assessments, including need for pretreatment regimen which includes antibiotics.